Experience with Immunology, Dermatology or Inflammation is a must.

Duties & Responsibilities

• Develop and execute global regulatory strategies to support the discovery, development, and registration of all company portfolio products for major markets such as the US.

• Lead global strategic and operational planning, management, support and execution of regulatory activities.

• Lead regulatory strategy making to support establishment of product’s Target Product Profile and Integrated Development Plan

• Builds and manages strong relationships with cross-functional internal colleagues, as well as between regulatory team and Health Authorities, external CROs, regulatory consulting groups, and other third parties.

• Define strategies and oversight the execution of regulatory submissions including but not limited to IND/CTAs, HA meetings/interactions, ODD, PIP/PSP/PPSR, DSUR, amendments and variations, etc.

• Serve as a key liaison to the US FDA, EU EMA, Australia TGA, Health Canada, and other key market Health Authorities

• Set up and establish in-house regulatory intelligence, landscape analysis, SOPs, dossier archiving, as well as internal training.

• Develops and maintains responsive, motivated, and efficient teams cross-culturally to ensure results-driven deliverables and continuous improvement.

Qualifications & Experience

• Master’s degree in a scientific discipline is required, doctoral degree (MD and/or PhD) or equivalent advanced degree is strongly preferred.

• Minimum of 10 years of regulatory experience in a pharmaceutical or biotechnology organization including significant experience in a regulatory strategic leadership role

• Regulatory experience with major authorities including FDA and EMA is required. Experience with other authorities e.g., Aus TGA, Health Canada

• Autoimmune experience is desirable

• Proven record of success in gaining major regulatory approvals (IND, CTA, NDA/BLA, ODD, etc.) from first-hand experience is required.

• Experience in organizing and leading major milestone meetings with FDA and/or EMA is required including Pre-IND, EoPh2 or pre-BLA meetings.

• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports and building or growing a cross-cultural global regulatory affairs function.

• Regulatory CMC, clinical pharmacology, or clinical-related experience is a plus. Familiar with CMC, PV, QA, and related aspects and connection with regulatory affairs.

• Excellent verbal and written communication skills